NCT06891326 Efficacy and Safety of tACS for Depression: a Multicenter RCT Study
| NCT ID | NCT06891326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Depression Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2025-09-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2024-10-08 with a primary completion date of 2025-09-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Transcranial alternating current stimulation (tACS) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. Randomized controlled trials (RCTs) of depression treated by tACS have been conducted but provided limited and incongruous results. We designed a multi-center RCT to evaluate the efficacy and safety of tACS for depression. Eligible participants will be patients diagnosed with depression (HDRS-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. A total of 72 participants will be recruited from 4 clinic centers. Participants will be randomized 1:1 to active tACS or sham stimulation group. The study staff and the participants are blinded to the randomization results. Stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (DLPFC) using frequency of 10Hz and amplitude of 1.5 to 2.0 mA. The intervention will last for 4 weeks, containing 20 40-minute sessions in total. Another 4-week observation will be followed by the end of the intervention. Participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. Psychological scales are used for the evaluation of their mental and quality of life. Besides, electroencephalogram (EEG) recording and magnetic resonance imaging (MRI) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.
Eligibility Criteria
Inclusion Criteria: 1. Clinical diagnosis of depressive disorder; 2. Age ranges between 18 and 65 years; 3. HDRS-17 score equals to or above 8; 4. No medical history/Under stable antidepressant treatment in one month; Exclusion Criteria: 1. Combination of other psychotic disorders and neurological diseases; 2. History of invasive brain surgeries; 3. Non-invasive neurostimulation treatments within 3 months; 4. Physical condition that may endanger patients' safety during the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06891326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depression Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06891326 currently recruiting?
Yes, NCT06891326 is actively recruiting participants. Contact the research team at wuyh_2022@163.com for enrollment information.
Where is the NCT06891326 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06891326 clinical trial?
NCT06891326 is sponsored by Ruijin Hospital. The trial plans to enroll 72 participants.
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